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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORBERA INTRAGASTRIC BALLOON SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBoston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP140008
Supplement NumberS001
Date Received08/31/2015
Decision Date03/02/2016
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the change in venders of manufacturing materials used to mold components of the ORBERA Intragastric Balloon System.
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